The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. Age ≥ 60 years; and
✓. Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator's clinical judgement based on criteria and testing as described in the iNPH Guidelines;
✓. Evans Ratio ≥ 0.30; and
✓. One positive supplementary test to include either large volume Lumbar Puncture or extended CSF drainage per institutional standards; and
✓. History or evidence of gait impairment (such as decreased step height or length, decreased speed, retropulsion as described in the iNPH Guidelines) duration ≥ 6 months; and
✓. Participant has the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial; and
✓. Participant is able to give written informed consent.
Exclusion criteria
✕. Unable to walk 10 meters with or without an assistive device; or
✕. Baseline fastest gait velocity (out of three gait trials) \>1 m/sec prior to drainage trial and fastest gait velocity improvement is \< 30% with or without an assistive device; or
✕. Unable to return to the study center for follow up evaluation and shunt programming; or
✕. Participant is not medically cleared for shunt surgery per local standards; or
. Secondary NPH. (Prior encephalitis, meningitis, subarachnoid hemorrhage, traumatic brain injury (including concussion) within two years or with brain injury or skull fracture on baseline imaging, brain abscess, brain tumor, obstructive hydrocephalus (including acquired aqueductal stenosis and carcinomatous meningitis); or
✕. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus; or
✕. Previous intracranial neurosurgical procedure; or
✕. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening (asymptomatic lacunar infarctions are permitted); or